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Comparison Between Efficacy of Topical 25%Podophyllin and Cryotherapy on Genital Warts

Comparison Between the Efficacy and Safety of Topical Podophyllin 25% Versus Cryotherapy in the Treatment of Anogenital Warts

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06809777
Enrollment
96
Registered
2025-02-05
Start date
2025-06-29
Completion date
2025-12-10
Last updated
2025-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anogenital Human Papilloma Virus Infection

Keywords

Anogenital warts, Topical 25% podophyllin, cryotherapy

Brief summary

Human papilloma virus (HPV), is the major prevalent cause of sexually transmitted disease affecting genitalia, causing Condylomata Accuminata, also known as external genital warts or anogenital warts.¹ Occurring in men and women with a prevalence rate of 0.6-1.2% worldwide. It primarily affects those in the age range of 20-25 years. Human papilloma virus infections subclinically are primarily caused by either type HPV- 6 or HPV- 11. A vast variety of treatment options are available to treat CA , including immunomodulators ( imiquimod, purified protein derivative and the HPV vaccine), physical ablation ( cryotherapy and electrodessication) and topical cytotoxic drugs ( TCA, phenol, 5- fluorouracil, retinoids, podophyllin and bleomycin)¹ . Although there are multiple effective treatment are present for EGW, no single treatment has been identified as the best ideal way to treat CA. Cryotherapy causes the destruction of keratinocytes infected with HPV by using below zero temperature and leading to thermal cell necrosis. Podophyllum peltatum and Podophyllum emodi are the main source of Podophyllin, a refined plant- based resin.¹² It works by attaching itself to the infected cell's microtubule disturbing the linking process which stops the mitotic process during the metaphase stage of cell division causing the death of epithelial cell. Study will include patients which will be divided into 2 groups A & B, 48 in each group. Group A will receive topical 25% podophyllin resin via cotton bud under supervision once weekly for 04 weeks. Group B will receive cryotherapy of 10sec freeze cycle twice weekly for 04 weeks. Patient will be followed at interval of 4 weeks and 8 weeks from start of treatment. Treatment will be considered efficant when decrease in the number of warts is clinically evident at follow up visits. Efficacy of treatment will be graded as 'excellent' \>90% clearance, 'good'60-89% clearance, 'satisfactory'30-59% clearance and 'poor'\<30% clearance.

Detailed description

Human papilloma virus (HPV), is the major prevalent cause of sexually transmitted disease affecting genitalia, causing Condylomata Accuminata, also known as external genital warts or anogenital warts. Occurring in men and women with a prevalence rate of 0.6-1.2% worldwide. It primarily affects those in the age range of 20-25 years. Human papilloma virus infections subclinically are primarily caused by either type HPV- 6 or HPV- 11.Topical medicines, surgeries and other treatment are among the many possible therapeutic options available. However recurrence and treatment failure are observed with almost all the available treatment after the warts have been visibly cleared. EGW management poses a major obstacle therapeutically . The patient's immunological condition determine the outcome of the warts , if they are left untreated , they could go away spontaneously, get bigger in size and numerous , or remain the same. The treatment goal is to remove visible warts in order to potentially reduce their infectious , if not the carcinogenic properties. In this study we will compare the efficacy of topical 25% podophyllin resin versus cryotherapy for the treatment of warts . Study will include patients which will be divided into 2 groups A & B, 48 in each group. Group A will receive topical 25% podophyllin resin via cotton bud under supervision once weekly for 04 weeks. Group B will receive cryotherapy of 10sec freeze cycle twice weekly for 04 weeks. Patient will be followed at interval of 4 weeks and 8 weeks from start of treatment. Treatment will be considered efficant when decrease in the number of warts is clinically evident at follow up visits. Efficacy of treatment will be graded as 'excellent' \>90% clearance, 'good'60-89% clearance, 'satisfactory'30-59% clearance and 'poor'\<30% clearance.

Interventions

DRUGTopical 25% podophyllin

25% podophyllin applied topically once weekly for 4 weeks

PROCEDURECryotherapy

cryotherapy of 10 sec freeze cycle applied twice weekly for 4 weeks

Sponsors

Sheikh Zayed Medical College
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Age: 16-60years * Gender: Any gender * All new clinically diagnosed cases of plane warts * Type of warts: plane warts * Area: Ano-genital warts * Size: Less than 10cm2(cummulative) * No. of warts: Upto 20 * Duration of disease: Any

Exclusion criteria

* Pregnancy and lactating females * Bleeding disorders * Immunocompromised patients. * Diabetic patients / Peripheral vascular disease. * Bleeding warts, moles, birthmarks. * Any other inflammatory dermatosis on that area * History of any previous treatment in last 2 months. * Liver/Renal disease * Hypersensitivity to Podophyllin.

Design outcomes

Primary

MeasureTime frameDescription
Efficacy of treatment will be graded as 'excellent' >90% clearance, 'good'60-89% clearance, 'satisfactory'30-59% clearance and 'poor'<306 monthsTreatment will be considered efficant when decrease in the number of warts is clinically evident at follow up visits at 4 weeks and 8 weeks after the start of treatment. Efficacy of treatment will be graded as 'excellent' \>90% clearance, 'good'60-89% clearance, 'satisfactory'30-59% clearance and 'poor'\<30% clearance.

Countries

Pakistan

Contacts

Primary ContactNarjis Batool, Post graduate resident
drnarjis99@gmail.com+923042937478

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026